NEUROFAX JE-120A-22

GUDID 00841983103810

Neurophysiologic monitoring system

Primary Device ID	00841983103810
NIH Device Record Key	b2478b36-c30e-40cf-ae65-f355b67d4d5d
Commercial Distribution Status	In Commercial Distribution
Brand Name	NEUROFAX
Version Model Number	JE-120A-22
Catalog Number	JE-120A-22
Company DUNS	021063219
Company Name	NIHON KOHDEN AMERICA, INC.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	true
Manufacturing Date	true
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00841983103810 [Primary]

OLT	Non-normalizing quantitative electroencephalograph software

Steralize Prior To Use	false
Device Is Sterile	false

00841983103988	MEDICAL ISOLATION TRANSFORMER
00841983103971	NEUROFAX ACQUISITION, Dell Precision Tower desktop
00841983103926	EEG REVIEW SUITE, 5 USER LICENSE
00841983103919	EEG REVIEW SUITE, 10 USER LICENSE
00841983103858	LIVE VIEW PANEL SYSTEM
00841983103841	EEG REVIEW SYSTEM
00841983103834	256 CHANNEL AMPLIFIER for JE-120A
00841983103827	192 CHANNEL AMPLIFIER for JE-120A
00841983103810	128 CHANNEL AMPLIFIER for JE-120A
00841983103803	NEUROFAX EEG DIGITAL, PORTABLE
00841983103797	NEUROFAX ACQUISITION, PANEL PC
00841983103773	NEUROFAX ACQUISITION, SML FRM
00841983103650	EEG REVIEW SUITE, MULTIUSE
00841983103209	NEUROFAX EEG DIGITAL, TOWER
00841983102417	Neurofax Electroencephalograph
00841983104329	NEUROFAX ACQUISITION, SML FRM

Mark Image Registration \| Serial	Company Trademark Application Date
NEUROFAX 73597401 1433703 Live/Registered	NIHON KOHDEN CORPORATION 1986-05-07